FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/09/095212 [Registered on: 22/09/2025] Trial Registered Prospectively
Last Modified On: 22/09/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Study of effect of marma chikitsa and ayurvedic drugs on the cases of newly diagnosed Type 2 Diabetes Mellitus. 
Scientific Title of Study   A clinical study of effect of Marma Chikitsa, Nisha-amalaki and Shilajatu on the cases of newly diagnosed Type 2 Diabetes Mellitus. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ARUNA SINGH 
Designation  Ph.D. scholar 
Affiliation  Banaras Hindu University 
Address  Department of Rachana sharir faculty of ayurveda IMS BHU varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  9580426534  
Fax    
Email  arunasingh8081@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  ARUNA SINGH 
Designation  Ph.D 
Affiliation  Banaras Hindu University 
Address  Department of Rachana sharir faculty of ayurveda IMS BHU varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  9580426534  
Fax    
Email  arunasingh8081@gmail.com  
 
Details of Contact Person
Public Query  
Name  HH Awasthi 
Designation  Senior Prof. 
Affiliation  Banaras Hindu University 
Address  Department of Rachana sharir faculty of ayurveda IMS BHU varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  9415813194  
Fax    
Email  hhawasthi10@yahoo.in  
 
Source of Monetary or Material Support  
Sir Sunderlal Hospital Faculty of Ayurveda IMS BHU Varansi 
 
Primary Sponsor  
Name  Institute of Medical Science Banaras Hindu University 
Address  Institute of Medical Science Banaras Hindu University 221005 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Nill  Nill 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ajai kumar pandey  Sir Sunderlal Hospital,BHU  Room no.22 department of kayachikitsa faculty of ayurveda Varanasi Uttar Pradesh
Varanasi
UTTAR PRADESH 		 9452827885

drajaipandey@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee Institute of Medical Sciences Banaras Hindu University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: PRAMEHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-marmacikitsA, मर्मचिकित्सा (Procedure Reference: none, Procedure details: Method of stimulation: Thumb & middle finger is placed over the medial & lateral points of Kurpara Marma & pressure is applied & released to stimulate the Marma point. )
2Comparator ArmDrugOther than Classical(1) Medicine Name: nisha amalaki, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -), Additional Information: -
3Intervention ArmDrugOther than Classical(1) Medicine Name: shilajatu, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: ), Additional Information:
(2) Medicine Name: shilajatu, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: ), Additional Information:
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patient having clinical feature and diagnostic criteria of diabetes mellitus
2.Pateint having fasting glucose level 126-200mg per dl(greater than 7.0mmolpermol)
3.Pateint having Hba1c 6.5to10 percent(greater than 48mmol/mol)
4.Pateint having post prandial blood glucose level 200 to 300mgperdl 
 
ExclusionCriteria 
Details  1.Pateint suffering from complications and other chronic diseases
2.Pateint having fasting glucose level less than126more than200mg per dl
3.Pateint having post prandial blood glucose level less than 200 more than 300mgperdl
4.Pateint having Hba1clower than 6.5 greater than10 percent
5.Pateint already on therapy for other cause
6.Pregnant and lactating women 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.blood sugar profile
2.lipid profile
3.physically examination 		 3 months with Follow up at 1 month interval 
 
Secondary Outcome  
Outcome  TimePoints 
Grading Scale for diabetic symptoms  months with Follow up at 1 month interval 
 
Target Sample Size   Total Sample Size="225"
Sample Size from India="225" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   20/10/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [arunasingh8081@gmail.com].

  6. For how long will this data be available start date provided 30-09-2025 and end date provided 30-09-2028?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information -  NIL
Brief Summary   225 cases of Diabetes Mellitus will be included in the interventional study which will be randomly divided into 3 groups of 75 in each group. one group will be controlled group prescibed  Metformin(500mg) OD before meal with water for a period of 3 month. Second group will be prescibed Nisha amalaki churna 6gm BD and Shiljatu capsule 500mg BD respectively with lukewarm water for a period of 3 month.  third group will be prescibed Nisha amalaki churna 6gm BD and Shiljatu capsule 500mg BD respectively with lukewarm water for a period of 3 month, three follow ups of marma chikitsa(kurpara marma) will be done at the interval of one month for over a period of 3 month. 
Close